FDA Announces Baxter’s Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection
On August 6, 2024, the U.S. Food and Drug Administration (FDA) reported that (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-one-lot-heparin-sodium-09-sodium-chloride-injection-due) Baxter International Inc. is voluntarily recalling one lot of heparin sodium in 0.9% sodium chloride injection to the consumer level because of the potential for elevated endotoxin levels.
Baxter said that it had discovered issues related to the bacterial endotoxin test specific to lot number N008235. Use of heparin with higher-than-acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death, the company reported. To date, Baxter said that it has not received any reports of adverse events related to the issue.
Heparin sodium in sodium chloride injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 ml, in VIAFLEX Plus plastic containers, one unit per pouch. The affected lot was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers, and distributors in the United States.
The affected product displays the following product code and lot number. The numbers can be found on the individual product and shipping carton.
| Product Code | Product Description | Lot Number | Expiry Date | NDC Number |
| 2B0944 | Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 ml | N008235 | 31-Aug-2024 | 0338-0433-04 |
Baxter voluntarily sent an urgent drug recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the urgent drug recall letter to return the affected product. Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at 888-229-0001 from 7 am–6 pm CT, Monday–Friday.
Customers should report any product quality complaints or adverse events experienced with the use of the products through one of the following options:
- Contacting Baxter Product Surveillance through the Baxter product feedback portal (https://productfeedback.baxter.com/) or emailing Baxter at corporate_product_complaints_round_lake@baxter.com (mailto:corporate_product_complaints_round_lake@baxter.com)
- Reporting to the FDA MedWatch Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda)